Bruno MA, Vanhaudenhuyse A, Thibaut A, Moonen G, Laureys S From unresponsive wakefulness to minimally conscious PLUS and functional locked-in syndromes: recent advances in our understanding of disorders of consciousness. J Neurol. 2011 Jul;258(7):1373-84. doi: 10.1007/s00415-011-6114-x. Epub 2011 Jun 16.
Giacino JT, Kalmar K, Whyte J The JFK Coma Recovery Scale-Revised: measurement characteristics and diagnostic utility. Arch Phys Med Rehabil. 2004 Dec;85(12):2020-9. doi: 10.1016/j.apmr.2004.02.033.
Golden K, Erler KS, Wong J, Giacino JT, Bodien YG Should Consistent Command-Following Be Added to the Criteria for Emergence From the Minimally Conscious State? Arch Phys Med Rehabil. 2022 Sep;103(9):1870-1873. doi: 10.1016/j.apmr.2022.03.010. Epub 2022 Apr 6.
Katz DI, Polyak M, Coughlan D, Nichols M, Roche A Natural history of recovery from brain injury after prolonged disorders of consciousness: outcome of patients admitted to inpatient rehabilitation with 1-4 year follow-up. Prog Brain Res. 2009;177:73-88. doi: 10.1016/S0079-6123(09)17707-5.
Song M, Yang Y, Yang Z, Cui Y, Yu S, He J, Jiang T Prognostic models for prolonged disorders of consciousness: an integrative review. Cell Mol Life Sci. 2020 Oct;77(20):3945-3961. doi: 10.1007/s00018-020-03512-z. Epub 2020 Apr 18.
Stineman MG, Ross RN, Fiedler R, Granger CV, Maislin G Functional independence staging: conceptual foundation, face validity, and empirical derivation. Arch Phys Med Rehabil. 2003 Jan;84(1):29-37. doi: 10.1053/apmr.2003.50061.
Thibaut A, Bodien YG, Laureys S, Giacino JT Minimally conscious state "plus": diagnostic criteria and relation to functional recovery. J Neurol. 2020 May;267(5):1245-1254. doi: 10.1007/s00415-019-09628-y. Epub 2019 Nov 26. Erratum In: J Neurol. 2020 Mar 19;:
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
